Bharat Biotech International Limited (BBIL), on Thursday announced that BBV152 (Covaxin), its whole-virion inactivated COVID-19 vaccine candidate, has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study.
Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age group, a press release from the vaccine maker said.
Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Covaxin’s clinical trial data from the paediatric population is very encouraging. Safety of the vaccine is critical for children and we are glad to share that Covaxin has now proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children.” The clinical trials conducted in the paediatric population between June-September 2021 have shown robust safety, reactogenicity, and immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021 and received emergency use nod for children aged 12-18 from DCGI recently.
In the study, no serious adverse event was reported. A total of 374 subjects reported either mild or moderate severity symptoms, with 78.6 per cent getting resolved within a day. Pain at the injection site was the most commonly reported adverse event, the release said.
For the trial, 976 subjects were screened for SARS-CoV-2 by RT-PCR and ELISA testing ( enzyme-linked immunoassay). Out of these, 525 eligible participants were enrolled. Based on the age, participants were distinguished into three groups in an age de-escalatory manner.